A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX4 + Weekly Cetuximab Versus FOLFOX4+ Biweekly Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer.
This multicenter randomized phase II study will enroll approximately 150 patients with
metastatic Colorectal Cancer. Patients are randomized in Arm A(FOLFOX4 in combination with
weekly Cetuximab) or Arm B (FOLFOX4 in combination with biweekly Cetuximab). Both efficacy
and safety data will be collected. The investigator will assess response to treatment every
8 weeks based on the imaging.
Following permanent treatment cessation, patients will be followed-up for survival.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of the trial is: • Objective response (CR/PR), as assessed by RECIST criteria
Objective response (partial or complete) will be assessed using RECIST criteria. The objective response rate (defined as the rate of subjects with complete response (CR) or partial response (PR)) will be estimated and associated exact two-sided 95% confidence limit (Clopper-Pearson) will be calculated. In addition to the estimates within each treatment group odds ratios and associated 95% CI will be calculated using the Cochran Mantel-Haenszel procedure.
The objective response rate - defined as the rate of subjects with complete response (CR) or partial response (PR)
Tudor Ciuleanu, Prof. Dr.
Institutul Oncologic of Cluj
Austria: Federal Ministry for Health and Women
CECOG /CORE 1.2.002